Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibro… (NCT05983471) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy and Safety of ME-015 (Suplatast Tosilate) in Cough Related to Idiopathic Pulmonary Fibrosis (COSMIC-IPF)
India40 participantsStarted 2024-04-01
Plain-language summary
Orally administered ME-015 (Suplatast Tosilate) has been available on the market as a prescription drug for allergy-related conditions in Japan since 1995 with a good safety and tolerability profile.
There is preclinical and exploratory clinical evidence suggesting that ME-015 may be effective in treating cough caused by idiopathic pulmonary fibrosis (IPF cough).
80% of patients with idiopathic pulmonary fibrosis (IPF) are affected by a devastating dry cough that is often not responsive to standard cough treatments and causes significant psychological and physiological suffering as well as reduced quality of life. As of November 2024, there is no approved treatment for IPF cough. There is an enormous unmet clinical need for an effective, safe and well-tolerated oral treatment; particularly as approved antifibrotic treatments (pirfenidone and nintedanib) have not been shown to reduce cough in controlled clinical trials.
The COSMIC-IPF Phase 2a trial is the first clinical trial assessing ME-015 (an NCE outside of Japan) for the treatment of IPF cough and aims to generate clinical proof-of-concept results regarding the safety and efficacy of ME-015 in this condition.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of IPF according to 2018 ATS/ERS/JRS/ALAT guidelines, confirmed by high-resolution computed tomography (HRCT) chest scan taken \< 2 years ago
✓. Age ≥ 18 years
✓. Cough attributed to IPF unresponsive to standard anti-tussive treatment and present for \> 8 weeks
✓. Arithmetic mean of ≥ 10 coughs/hour during waking hours
✓. Ability to read, comprehend, and complete the ICF and all questionnaires in the study without help
✓. Cough severity score of ≥ 40 mm on a 0-to-100 mm Visual Analogue Scale (VAS)
✓. Willing and able to comply with the protocol
✓. Life expectancy \> 6 months
Exclusion criteria
✕. Likely need for lung transplantation in next 12 months
✕. Permanent long-term oxygen therapy
What they're measuring
1
Wake time cough frequency during 24 hours
Timeframe: Change from Baseline to Day 14 in the respective treatment period